Identifying Vit D Deficiency in VLBW Infants Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Intestinal Calcium Absorption
研究概览
简要总结
This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any infant born at the Medical University of South Carolina <34 weeks gestation
- •Less that 1500g at birth
- •Must be African American or Caucasian
- •Each infant born of twin and triplet pregnancies will be eligible
排除标准
- •Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
- •Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
- •Maternal uncontrolled thyroid disease
- •Maternal Parathyroid disease
- •Infants of races other than African American or Caucasian
结局指标
主要结局
Intestinal Calcium Absorption
时间窗: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
Parathyroid hormone concentration
时间窗: At term age (expected 2-4 months)
Serum 25 hydroxyvitamin D status
时间窗: At term age (expected 2-4 months)
Bone Health
时间窗: At term age (expected 2-4 months)
Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.
Serum inflammatory cytokine concentrations
时间窗: At birth (day 1)
次要结局
- Phosphorus Homeostasis(At term age (expected 2-4 months))
- Growth parameters(At term age (expected 2-4 months))
- Vitamin D Dose Safety as Measured by Urinary Calcium Excretion(At term age (expected 2-4 months))
研究者
Sarah N Taylor
Assistant Professor of Pediatrics, Medical University of SC
Medical University of South Carolina